The Ministry of Health (MOH) in Vietnam issued Circular 29/2024/TT-BYT on November 3, 2024, mandating the price declaration of certain medical devices based on their technical and economic characteristics. This circular specifies the requirements for declaring prices, including the product name and specific model, and will take effect on January 1, 2025:
| Specific model | Detailed product name (following the approved license) |
|---|---|
| Artificial kidney Machine | Artificial kidney Machine |
| Ventilator | Ventilator |
| Resuscitation high frequency ventilator for newborns and children | |
| Ventilator for newborns and children | |
| Ventilator for newborns | |
| Portable ventilator | |
| Non-invasive ventilator for newborns | |
| Anesthesia Machine | Anesthesia Machine |
| Anesthesia breathing Machine | |
| Anesthesia breathing Machine used in magnetic-resonance imaging room | |
| Patient Monitoring Machine | Patient Monitoring Machine |
| Central Patient Monitoring Machine | |
| Electric syringe pump | Electric syringe pump |
| Target Controlled Syringe Pump TCI | |
| Electric syringe pump used for MRI machine | |
| Infusion Machine | Infusion Machine |
| Defibrillator | Defibrillator |
| Pacemaker defibrillator | |
| Automatic defibrillator | |
| Electric bistoury | Electric bistoury |
| High frequency electric bistoury | |
| High frequency electric bistoury with vessel sealer function | |
| Plasma high frequency electric bistoury | |
| Ultrasound high frequency electric bistoury | |
| X-ray Systems/Machine | Dental and otolaryngology X-ray Systems |
| Digital X-ray Systems | |
| Fixed high frequency X-ray Systems | |
| Diagnostic X-ray Systems | |
| Specific model | Detailed product name (following the approved license) |
| X-ray Systems/Machine | Digital imaging X-ray Systems |
| Portable X-ray Systems | |
| Twin Robotic X-ray system | |
| Digital X-ray Systems | |
| DR digital X-ray Systems | |
| Mammography X-ray Systems | |
| Brightness enhancement X-ray system | |
| X-ray imaging machine | |
| Hand-held X-ray imaging machine | |
| Dental scanning X-ray imaging machine | |
| Portable X-ray imaging machine | |
| Digital X-ray imaging machine | |
| Dental X-ray imaging machine | |
| Brightness enhancement X-ray machine | |
| High frequency X-ray machine | |
| C-arm X-ray machine | |
| Portable C-arm X-ray machine | |
| Digital imaging portable C-arm X-ray machine | |
| Digital portable C-arm X-ray machine | |
| Diagnostic X-ray machine | |
| Digital diagnostic X-ray machine | |
| Digital imaging X-ray machine | |
| Mammography X-ray machine | |
| Portable X-ray machine | |
| Portable high frequency X-ray machine | |
| Portable digital X-ray machine | |
| Digital X-ray machine | |
| Dental X-ray machine | |
| Teeth X-ray machine | |
| Panoramic dental X-ray machine |
MOH’s Role in Price Declaration and Compliance
The Ministry of Health has tasked the Infrastructure and Medical Device Administration (IMDA) with overseeing and facilitating the price declaration process in collaboration with other relevant ministries. Key responsibilities of IMDA include:
- Publishing accepted forms for price declaration applications
- Developing a dedicated web portal for price declaration submissions
- Compiling and maintaining a list of business entities involved in the sale of medical devices required to declare prices
- Updating the price declaration data within the National Database
- Reviewing and amending the economic and technical criteria for price declaration semiannually
Further Information and Resources
For more detailed information on this regulation, please refer to Circular 29-TT-BYT List of Medical Devices for Price Declaration (PDF in Vietnamese).
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